NATICK, Mass. (AP) - Boston Scientific Corp. said it would immediately launch a new stent that props open arteries and releases drugs into them after receiving final approval Thursday from federal regulators.
The approval was expected following the unanimous recommendation by a Food and Drug Administration advisory panel in November. The device will compete with a product made by a Johnson & Johnson subsidiary that is already on the market.
"This approval is a breakthrough event for the treatment of cardiovascular disease in the United States," said Jim Tobin, Boston Scientific's president and chief executive officer.
Boston Scientific launched the Taxus Express2 stent in Europe in February.
Last month, Guidant Corp. of Indianapolis and Miami Lakes, Fla.-based Cordis Corp., a unit of Johnson & Johnson, said they would settle patent suits and join forces to develop and market stent technology.
Minneapolis-based Medtronic expects to introduce its drug-coated stent in the United States in late 2005.
Stents are tiny scaffold-like mesh-metal tubes implanted into coronary arteries to prevent new blockages. The new models are coated with slow-release drugs to prevent scar tissue from forming.
Before the announcement, shares of Boston Scientific closed up 97 cents at $44.12 on the New York Stock Exchange.